SOOTHE COMFORT II COUGH SYRUP HERBAL MINT- dextromethorphan liquid 
RFX Pharmaceutical Co., Ltd.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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RFXLMSootheComfortIICghSyrp

Active ingredient (in each 30 ml/2TBSP)

Dextromethorphan 30 mg

Purpose

Cough suppressant

Use

■ temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold

Warnings

Do not use

■ if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

■cough that occurs with too much phlegm (mucus)

■cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema

Stop use and ask a doctor if

■ cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

If pregnant or breast-feeding

ask a health professional before use

Keep out of reach of children

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

■ do not take more than 4 doses in any 24-hour period

■ one dose is two tablespoons (TBSP)

■ this adult product is not intended for use in children under 12 years of age

Age Dose

adults and children 12 years 30 mL (2TBSP)

and over every 6 hours

children 4 to under 12 years ask a doctor

children under 4 years do not use

Other Information

■ store at 20-25ºC (68-77ºF). Do not refrigerate

Inactive ingredients

coltsfoot flower bud extract, grosvenor momordica fruit extract, honey, peppermint extract, schisandra chinensis fruit extract, sichuan fritillary bulb extract, water, white mulberry root bark extract

Questions or comments?

■ 1-800-860-0888

Package Label

package label

SOOTHE COMFORT II COUGH SYRUP  HERBAL MINT
dextromethorphan liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76206-005
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN (UNII: 7355X3ROTS) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE30 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
MORUS ALBA ROOT BARK (UNII: SV6B76DK9N)  
TUSSILAGO FARFARA FLOWER BUD (UNII: 6WBB6U5V2Q)  
HONEY (UNII: Y9H1V576FH)  
FRITILLARIA PRZEWALSKII BULB (UNII: 8B269H8XVH)  
SCHISANDRA CHINENSIS FRUIT OIL (UNII: 62023A4393)  
SIRAITIA GROSVENORII FRUIT (UNII: NOU2FB51TW)  
WATER (UNII: 059QF0KO0R)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
Product Characteristics
Colorbrown (light brown) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76206-005-011 in 1 BOX04/23/2021
1NDC:76206-005-05155 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34104/23/2021
Labeler - RFX Pharmaceutical Co., Ltd. (530620871)

Revised: 4/2021
Document Id: c10b6899-a3d2-6f27-e053-2a95a90a6927
Set id: c10b5649-c79a-7805-e053-2a95a90ae865
Version: 1
Effective Time: 20210428
 
RFX Pharmaceutical Co., Ltd.